NANOSAFE 2016
Grenoble, 8th October 2016
Implementation of a safe-by-design
approach in the construction of three
open pilot plants for manufacturing
nano-enabled products targeted to the
European aeronautics and automotive
industries
Jesús M. López de Ipiña1, Sonia Florez1, Richard Seddon1, Angel Hernan2,
Xabier Cenigaonaindia2, Mario Insunza2, Antonios Vavouliotis3, Vasilios
Kostopoulos4, Paulina Latko5, Paweł Durałek6
(1) TECNALIA, (2) Sisteplant SL, (3) Adamant Composites Ltd., (4) University of Patras, (5) Technology Partners Foundation, (6) TMBK Partners
Index
Project PLATFORM (GA 646307)
Project consortium
PLATFORM framework for safe product and safe production
Motivation and context
The regulatory framework for the safe design and putting into service the PPPs
SbD principles of the Machinery Directive
Link between EHSRs (mandatory) and harmonized standards (voluntary)
Harmonized standards
Five steps for the design, construction and putting into service the PPPs according to MD
requirements (EHSRs)
Safe by Design (SbD) and Safety Integration
Systematic and iterative approach for risk assessment and risk reduction (EN - ISO 12100)
PLATFORM SbD Tool (v1)
Strategies for airborne emissions verification (EN ISO 14123-1)
To summarize
2 ▌
Open access pilot plant for sustainable industrial scale nanocomposites
manufacturing based on buckypapers, doped veils and prepregs (PLATFORM)
The final objective of project PLATFORM is to put into service and operate, in the shortterm (2020), three NEW PLATFORM Pilot Plants ( PPPs) for the INDUSTRIAL PRODUCTION
and COMMERCIALIZATION of nano-enabled products (bucky papers, treated prepegs, and
doped non-woven veils) (TRL6 2018, TRL9 2020 – Business Platform)
PLATFORM consortium
SbD
PLATFORM framework for safe product and safe production
Motivation and context
 The future commercialization needs as well as the intended
use of PPPs by third parties force the design and
construction of PPPs in conformity with legal requirements
(CE marking), before putting them into service and made
available to workers.
 The Machinery Directive 2006/42/EC (MD) is the European
regulatory framework for the design and construction of
new machinery - as future PPPs.
 PPPs are not required to comply with the provisions of
Directive 2006/42/EC until they are put into service
(expected in 2020). But in 2020, all requirements of the
MD will be mandatory for PPPs.
The regulatory framework for the safe design and putting into
service the PPPs: The Machinery Directive 2006/42/EC (MD)
6 ▌
Motivation and context
 In this regulatory context, project Platform is
conducting the design of PPPs to comply with all the
provisions of the MD to:
1) facilitate the CE marking in 2020 (TRL9), as well as
2) avoid potential economic costs associated with
future re-adaptations or modifications needed to
ensure compliance with MD, when PPPs are put
into service.
 The major project CHALLENGE is to integrate all
nanosafety issues in the well established SbD process
of machinery according to MD.
7 ▌
SbD principles of the Machinery Directive
Principles of Safety Integration (SbD) often referred to as
the 3-step method (MD):
1. Eliminate or reduce risks as far as possible (inherently
safe machinery design and construction),
2. Take the necessary protective measures in relation to
risks that cannot be eliminated,
3. Inform users of the residual risks due to any
shortcomings of the protective measures adopted, indicate
whether any particular training is required and specify any
need to provide personal protective equipment.
Prevention through Design (PtD), Safe-by-Design (SbD) or
Safety Integration (SI) are similar concepts that refer to design
out hazards or minimize risks early in the design process.
8 ▌
Nano
Decision making
 The Directive sets out the mandatory ESSENTIAL HEALTH AND SAFETY
REQUIREMENTS (EHSRs) for machinery while detailed technical specifications
for fulfilling these requirements are given in European harmonised standards.
 Machinery manufactured in conformity with a harmonised standard shall be
presumed to comply with the EHSRs covered by such a harmonised standard.
 Thus harmonised standards are essential tools for applying the Machinery
Directive.
 Harmonised standars: A, B and C-types
 No harmonized standards for nanosafety
Link between EHSRs (mandatory) and harmonized standards
(voluntary)
9 ▌
Nano
Decision making
Harmonized standards
10 ▌
Nano
Decision making
Five steps for the design, construction and putting into
service the PPPs according to MD requirements (EHSRs)
11 ▌
2. HAZARD IDENTIFICATION AND 3. RISK ESTIMATION (ISO/TR 14121-2:2012)
#
Machine zone
Life step
Operating mode
Task
4. RISK EVALUATION AND RISK REDUCTION (ISO/TR 14121-2:2012)
Risk (before)
Risk (After)
Hazard
Hazardous situation
Hazardous event
Sev
Frec
Prob
Avoid
Class CI
SIL
Description
Sev
Frec
Prob
Avoid
Class CI
SIL
1
HZ1
Dispersion
preparation
Com
Commissioning
A
Automatic
T1.1
Raw material
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Operator feeding (pouring) the CNT dissolution
(dissolution containing MWCNT)
Emission (leaking or splashing) of a fluid
containing MWCNT.
3
5
3
3
11
HIGH
A safety containment tank located under the risk area with enough
capacity, Use of protective equipment (gloves, chemical glasses,
protective clothing). Automated fluid transferring system (pump)
3
2
1
1
4
LOW
2
HZ1
Dispersion
preparation
Com
Commissioning
M1
Manual 1
T1.1
Raw material
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Operator feeding (pouring) the CNT dissolution
(dissolution containing MWCNT)
Emission (leaking or splashing) of a fluid
containing MWCNT.
3
5
3
3
11
HIGH
A safety containment tank located under the risk area with enough
capacity, Use of protective equipment (gloves, chemical glasses,
protective clothing). Automated fluid transferring system (pump)
3
2
1
1
4
LOW
3
HZ1
Dispersion
preparation
Use
Use
A
Automatic
T1.1
Raw material
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Operator feeding (pouring) the CNT dissolution
(dissolution containing MWCNT)
Emission (leaking or splashing) of a fluid
containing MWCNT.
3
5
3
3
11
HIGH
A safety containment tank located under the risk area with enough
capacity, Use of protective equipment (gloves, chemical glasses,
protective clothing). Automated fluid transferring system (pump)
3
2
1
1
4
LOW
4
HZ1
Dispersion
preparation
Use
Use
M1
Manual 1
T1.1
Raw material
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Operator feeding (pouring) the CNT dissolution
(dissolution containing MWCNT)
Emission (leaking or splashing) of a fluid
containing MWCNT.
3
5
3
3
11
HIGH
A safety containment tank located under the risk area with enough
capacity, Use of protective equipment (gloves, chemical glasses,
protective clothing). Automated fluid transferring system (pump)
3
2
1
1
4
LOW
5
HZ1
Dispersion
preparation
Com
Commissioning
A
Automatic
T1.3
Feeding filtering
stage
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Operator pouring the sonicated CNT dissolution
(dissolution containing MWCNT)
Emission (leaking or splashing) of a fluid
containing MWCNT.
3
5
3
3
11
HIGH
A safety containment tank located under the risk area with enough
capacity, Use of protective equipment (gloves, chemical glasses,
protective clothing). Automated fluid transferring system (pump)
3
2
1
1
4
LOW
6
HZ1
Dispersion
preparation
Com
Commissioning
M1
Manual 1
T1.3
Feeding filtering
stage
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Operator pouring the sonicated CNT dissolution
(dissolution containing MWCNT)
Emission (leaking or splashing) of a fluid
containing MWCNT.
3
5
3
3
11
HIGH
A safety containment tank located under the risk area with enough
capacity, Use of protective equipment (gloves, chemical glasses,
protective clothing). Automated fluid transferring system (pump)
3
2
1
1
4
LOW
7
HZ1
Dispersion
preparation
Use
Use
A
Automatic
T1.3
Feeding filtering
stage
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Operator pouring the sonicated CNT dissolution
(dissolution containing MWCNT)
Emission (leaking or splashing) of a fluid
containing MWCNT.
3
5
3
3
11
HIGH
A safety containment tank located under the risk area with enough
capacity, Use of protective equipment (gloves, chemical glasses,
protective clothing). Automated fluid transferring system (pump)
3
2
1
1
4
LOW
8
HZ1
Dispersion
preparation
Use
Use
M1
Manual 1
T1.3
Feeding filtering
stage
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Operator pouring the sonicated CNT dissolution
(dissolution containing MWCNT)
Emission (leaking or splashing) of a fluid
containing MWCNT.
3
5
3
3
11
HIGH
A safety containment tank located under the risk area with enough
capacity, Use of protective equipment (gloves, chemical glasses,
protective clothing). Automated fluid transferring system (pump)
3
2
1
1
4
LOW
Dispersion
Clean
preparation
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Cleaning and maintenance of the sonication tip or
container (Waste water containing MWCNT)
Contact with a fluid containing MWCNT in
container/sonication tip
3
4
4
3
11
HIGH
Procedure for cleaning and maintenance, training
3
4
2
1
7
MEDIUM
Filtering stage is running
Filter break up during operation
3
3
3
3
9
HIGH
Filter friction dimensioning on design and tension control (vacuum
measure, rolling radius, motor torque, motor power)
3
2
1
1
4
LOW
Filtering stage is running
The filter roll is ended and there is no more
filter to be fed
3
4
4
3
11
HIGH
Sensor to detect roll ending
3
2
2
1
5
MEDIUM
Filtering stage is running
Waste water container (containing
MWCNT ) is overfilled and waste water
leakage occurs.
3
4
4
3
11
HIGH
3
2
2
1
5
MEDIUM
0
9
HZ1
Cleaning
S
Stop
T1.4
Cleaning
10
HZ2
Filtering
Com
Commissioning
A
Automatic
T2,3
Machine start-up
11
HZ2
Filtering
Com
Commissioning
A
Automatic
T2,3
Machine start-up
12
HZ6
Waste
water
disposal
Com
Commissioning
A
Automatic
T2,3
Machine start-up
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
13
HZ2
Filtering
Com
Commissioning
M1
Manual 1
T2,3
Machine start-up
14
HZ2
Filtering
Com
Commissioning
M1
Manual 1
T2,3
Machine start-up
15
HZ6
Waste
water
disposal
Com
Commissioning
M1
Manual 1
T2,3
Machine start-up
16
HZ2
Filtering
Use
Use
A
Automatic
T2,3
Machine start-up
17
HZ2
Filtering
Use
Use
A
Automatic
T2,3
Machine start-up
18
HZ6
Waste
water
disposal
Use
Use
A
Automatic
T2,3
Machine start-up
19
HZ2
Filtering
Use
Use
M1
Manual 1
T2,3
Machine start-up
20
HZ2
Filtering
Use
Use
M1
Manual 1
T2,3
Machine start-up
21
HZ6
Waste
water
disposal
Use
Use
M1
Manual 1
T2,3
Machine start-up
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Operator passing a new filter through the rollers
22
HZ2
Filtering
Com
23
HZ2
Filtering
Com
24
HZ2
Filtering
Set
25
HZ2
Filtering
Set
26
HZ7
27
HZ7
28
HZ7
29
HZ7
30
HZ2
31
HZ3
Peeling 1
(filtrationwashing)
Peeling 1
(filtrationwashing)
Peeling 1
(filtrationwashing)
Peeling 1
(filtrationwashing)
Filtering
Washing
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Filtering stage is running
Filter break up during operation
3
3
3
3
9
HIGH
Filtering stage is running
The filter roll is ended and there is no more
filter to be fed
3
4
4
3
11
HIGH
Filtering stage is running
Waste water container (containing
MWCNT ) is overfilled and waste water
leakage occurs.
3
4
4
3
11
HIGH
Filtering stage is running
Filter break up during operation
3
3
3
3
9
HIGH
Filtering stage is running
The filter roll is ended and there is no more
filter to be fed
3
4
4
3
11
HIGH
Filtering stage is running
Waste water container (containing
MWCNT ) is overfilled and waste water
leakage occurs.
3
4
4
3
11
HIGH
Filtering stage is running
Filter break up during operation
3
3
3
3
9
HIGH
Filtering stage is running
The filter roll is ended and there is no more
filter to be fed
3
4
4
3
11
HIGH
Filtering stage is running
Waste water container (containing
MWCNT ) is overfilled and waste water
leakage occurs.
3
4
4
3
11
HIGH
Commissioning
A
Automatic
T2.1
Adding filter
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Commissioning
M1
Manual 1
T2.1
Adding filter
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Operator adding filter under the vacuum chamber
A
Automatic
T2.1
Adding filter
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Operator adding filter under the vacuum chamber
M1
Manual 1
T2.1
Adding filter
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Operator adding filter under the vacuum chamber
Adjustment, setting
or process/tool
changeover
Adjustment, setting
or process/tool
changeover
Measures /solutions for Risk reduction
Contact with residual fluid containing
MWCNT under the vacuum chamber or
the used filter
Contact with residual fluid containing
MWCNT under the vacuum chamber or
the used filter
Contact with residual fluid containing
MWCNT under the vacuum chamber or
the used filter
Contact with residual fluid containing
MWCNT under the vacuum chamber or
the used filter
Waste water container level sensor with appropriate safety level
(duplication if needed) and normal stop when level reached (safety
extra space must be let in the container for filtration during normal
stopping operation.
Filter friction dimensioning on design and tension control (vacuum
measure, rolling radius, motor torque, motor power)
Standards
X
Performance Level (PL) estimation (EN ISO 13849-1: 2015)
X
X
Performance Level (PL) estimation (EN ISO 13849-1: 2015)
X
X
3
2
1
1
4
LOW
X
X
3
2
2
1
5
MEDIUM
Performance Level (PL) estimation (EN ISO 13849-1: 2015)
X
X
3
2
2
1
5
MEDIUM
Performance Level (PL) estimation (EN ISO 13849-1: 2015)
X
X
3
2
1
1
4
LOW
X
X
3
2
2
1
5
MEDIUM
Performance Level (PL) estimation (EN ISO 13849-1: 2015)
X
X
3
2
2
1
5
MEDIUM
Performance Level (PL) estimation (EN ISO 13849-1: 2015)
X
X
3
2
1
1
4
LOW
X
X
Sensor to detect roll ending
3
2
2
1
5
MEDIUM
Performance Level (PL) estimation (EN ISO 13849-1: 2015)
X
X
Waste water container level sensor with appropriate safety level
(duplication if needed) and normal stop when level reached (safety
extra space must be let in the container for filtration during normal
stopping operation.
3
2
2
1
5
MEDIUM
Performance Level (PL) estimation (EN ISO 13849-1: 2015)
X
X
Sensor to detect roll ending
Waste water container level sensor with appropriate safety level
(duplication if needed) and normal stop when level reached (safety
extra space must be let in the container for filtration during normal
stopping operation.
Filter friction dimensioning on design and tension control (vacuum
measure, rolling radius, motor torque, motor power)
Sensor to detect roll ending
Waste water container level sensor with appropriate safety level
(duplication if needed) and normal stop when level reached (safety
extra space must be let in the container for filtration during normal
stopping operation.
Filter friction dimensioning on design and tension control (vacuum
measure, rolling radius, motor torque, motor power)
5
12
HIGH
3
2
1
1
4
LOW
X
X
5
12
HIGH
Joining the new filter with the previous one so that the previous filter
guides the new one.
3
2
1
1
4
LOW
X
X
5
12
HIGH
Joining the new filter with the previous one so that the previous filter
guides the new one.
3
2
1
1
4
LOW
X
X
3
5
12
HIGH
Joining the new filter with the previous one so that the previous filter
guides the new one.
3
2
1
1
4
LOW
X
X
3
2
1
1
4
LOW
UNE-EN 455: Guantes médicos para un solo uso.
EN 374: Guantes de protección contra los productos químicos
y los microorganismos.
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Buckypaper is peeled from the filter
Contact with wet Buckypaper containing
MWCN
3
5
4
5
14
HIGH
Use of protective equipment: gloves, chemical glasses, protective
clothing)
3
2
1
1
4
LOW
UNE-EN 455: Guantes médicos para un solo uso.
EN 374: Guantes de protección contra los productos químicos
y los microorganismos.
Use
Use
A
Automatic
T2.1
Adding filter
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Buckypaper is peeled from the filter
Contact with wet Buckypaper containing
MWCN
3
5
4
5
14
HIGH
Use of protective equipment: gloves, chemical glasses, protective
clothing)
3
2
1
1
4
LOW
UNE-EN 455: Guantes médicos para un solo uso.
EN 374: Guantes de protección contra los productos químicos
y los microorganismos.
Use
Use
M1
Manual 1
T2.1
Adding filter
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Buckypaper is peeled from the filter
Contact with wet Buckypaper containing
MWCN
3
5
4
5
14
HIGH
Use of protective equipment: gloves, chemical glasses, protective
clothing)
3
2
1
1
4
LOW
UNE-EN 455: Guantes médicos para un solo uso.
EN 374: Guantes de protección contra los productos químicos
y los microorganismos.
Clean
Cleaning
EP
End production
T2.5
Cleaning
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Operator cleaning the pool and the vacuum chamber
Contact with residual fluid in container
containing MWCNT
3
4
4
3
11
HIGH
Procedure for cleaning and maintenance, training
3
4
2
1
7
MEDIUM
Adding filter
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Operator pouring the distilled water from the pool
Contact with residual fluid in container
containing MWCNT
HIGH
A safety containment tank located under the risk area with enough
capacity, Use of protective equipment (gloves, chemical glasses,
protective clothing). Automated fluid transferring system (pump)
Com
Commissioning
A
Automatic
T3.1
Adding filter
Washing
Com
Commissioning
M2
Manual 2
T3.1
Adding filter
Washing
Set
Adjustment, setting
or process/tool
changeover
A
Automatic
T3.1
Adding filter
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Buckypaper is peeled from the filter
3
5
4
5
14
HIGH
Use of protective equipment: gloves, chemical glasses, protective
clothing)
Operator adding filter under the vacuum chamber
Operator adding filter under the vacuum chamber
Operator adding filter under the vacuum chamber
Contact with residual fluid in container
containing MWCNT
X
3
Adding filter
Washing
X
3
T2.1
HZ3
X
3
Manual 1
HZ3
X
4
M1
HZ3
X
4
Commissioning
34
X
X
4
Com
33
X
X
4
Adding filter
32
X
X
3
Contact with wet Buckypaper containing
MWCN
Contact with residual fluid in container
containing MWCNT
Contact with residual fluid in container
containing MWCNT
X
X
3
T2.1
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
X
X
3
Automatic
T3.1
X
X
3
A
Automatic
X
X
Joining the new filter with the previous one so that the previous filter
guides the new one.
Commissioning
A
X
X
Com
Commissioning
M FT DV C
X
Exposure to MWCNT by ingestion, contact with skin, eyes or
mucous membranes or penetration through skin
Com
Verification
VI
Dangerous materials managing standards / rules
UNE-EN 455: Guantes médicos para un solo uso.
EN 374: Guantes de protección contra los productos químicos
y los microorganismos.
Dangerous materials managing standards / rules
UNE-EN 455: Guantes médicos para un solo uso.
EN 374: Guantes de protección contra los productos químicos
y los microorganismos.
Dangerous materials managing standards / rules
UNE-EN 455: Guantes médicos para un solo uso.
EN 374: Guantes de protección contra los productos químicos
y los microorganismos.
Dangerous materials managing standards / rules
UNE-EN 455: Guantes médicos para un solo uso.
EN 374: Guantes de protección contra los productos químicos
y los microorganismos.
Dangerous materials managing standards / rules
UNE-EN 455: Guantes médicos para un solo uso.
EN 374: Guantes de protección contra los productos químicos
y los microorganismos.
Dangerous materials managing standards / rules
UNE-EN 455: Guantes médicos para un solo uso.
EN 374: Guantes de protección contra los productos químicos
y los microorganismos.
Dangerous materials managing standards / rules
UNE-EN 455: Guantes médicos para un solo uso.
EN 374: Guantes de protección contra los productos químicos
y los microorganismos.
Dangerous materials managing standards / rules
UNE-EN 455: Guantes médicos para un solo uso.
EN 374: Guantes de protección contra los productos químicos
y los microorganismos.
3
4
3
3
10
3
4
3
3
10
3
4
3
3
10
3
3
4
3
3
10
HIGH
HIGH
Joining the new filter with the previous one so that the previous filter
guides the new one.
Joining the new filter with the previous one so that the previous filter
guides the new one.
Joining the new filter with the previous one so that the previous filter
guides the new one.
X
X
X
X
X
Dangerous materials managing standards / rules
UNE-EN 455: Guantes médicos para un solo uso.
EN 374: Guantes de protección contra los productos químicos
y los microorganismos.
3
2
1
1
4
LOW
3
2
1
1
4
LOW
X
X
3
2
1
1
4
3
X
X
3
2
1
1
4
LOW
X
X
X
X
The process has been guided by the
harmonized standard EN ISO 12100 (and
EN-ISO 14123-1,2), taking the relevant
phases of life cycle, expected uses and
operation modes of PPPs into account
Systematic and iterative approach for risk assessment and risk reduction followed to
eliminate hazards as far practicable and to adequately reduce risks by the implementation
of protective measures (EN - ISO 12100)
Fuente: EN ISO 12100
 PLATFORM – SbD Tool (v1) is a simple and friendly
Microsoft Excel tool to guide the safe design and
risk assessment of PPPs, in accordance with the
EHSRs of the Directive 2006/42/EC.
 This tool can be applied to the overall risk
assessment of PPPs or only for risks related to the
use and handling of ENMs and NEPs.
PLATFORM SbD Tool (v1)
Excel spreadsheet to document the stages of hazard identification, risk estimation,
risk evaluation and risk reduction of the risk assessment & risk reduction process,
including the verification of the measures / solutions required for adequate risk
reduction.
Excel spreadsheet to evaluate and document the Safety Integrity Levels (SIL) and
Performance Levels (PL) required by the control systems of PPPs related to safety
functions.
Verification
Strategy 1: Measuring PPPs airborne emissions and the
performance of the control systems integrated in these machines,
in general, according to EN 1093-1.
On-line measurement
using CPC-OPC + Laser Induced
Incandescence LII-EC (AT) will be explored .
Strategy 2: Measuring PPPs immissions. If strategy 1 is technically
unfeasible, indirect technique, by measuring the occupational
exposure of the workers and comparing such measurements with
suitable criteria.
Occupational exposure to all types of CNT can be quantified using
NIOSH Method 5040 (Personal sampling + offsite analysis, including
TEM). NIOSH REL of 1 μg/m3 8-hr TWA (NANOCYL 2,5 μg/m3).
Strategies for airborne emissions verification (EN ISO 14123-1)
To summarize
1. PPPs design: SbD following MD principles for safety
integration and integrating all relevant nanosafety aspects
to achieve final safe designs in conformity with relevant
EHSRs (Technical File).
2. PPPs construction: according to the SbD produced in step 1
and in a controlled dedicated room.
3. PPPs - SbD verification by: 1) Visual inspection, 2)
Measurement, 3) Functional testing, 4) Design validation or
5) Calculation.
4. PPPs putting into service and CE marking: after fulfilling all
the obligations relating to the conformity with the MD.
Strategy for PPPs design, construction and putting into service
18 ▌
Thank you very much
for your attention!
(jesus.lopezdeipina@tecnalia.com)
Project PLATFORM have received funding from the European Union’s Horizon 2020 research and
innovation programme, under grant agreement No 646307. This presentation reflects only the
author’s views and the Commission is not responsible for any use that may be made of the information
contained therein.
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